(205 days)
Not Found
No
The description details a physical, manually operated pipette made of glass. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML.
No.
The device is used to remove cells for genetic diagnosis, not to treat a disease or condition.
No
Explanation: The device is a biopsy pipette used for removing cells for preimplantation genetic diagnosis (PGD), but it is a tool for obtaining specimens, not for performing the diagnosis itself.
No
The device description clearly states the device is a physical pipette made of borosilicate glass, which is a hardware component.
Based on the provided information, the device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the pipettes are used for "removal of blastomere(s) from embryos or polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic materials in the biopsied cell(s)." PGD is a genetic test performed on cells to diagnose genetic conditions before implantation. This directly relates to providing information about a patient's health status (in this case, the potential genetic health of the embryo/oocyte).
- Function: The device is used to obtain a sample (cells) for subsequent in vitro diagnostic testing (PGD). While the pipette itself doesn't perform the diagnostic test, it is an essential tool for obtaining the specimen required for the test.
- Context of Use: The use in "assisted reproduction techniques (ART)" further supports the IVD classification, as ART often involves procedures that lead to in vitro diagnostic testing of embryos or gametes.
- Predicate Devices: The listed predicate devices, K991261 and K012811, are described as "RI Pipettes - ICSI Injection, Holding, Assisted Hatching, Denuding" and "Polar body biopsy micropipet and blastomere biopsy micropipet." These types of devices are commonly classified as IVDs or accessories to IVDs because they are used to prepare samples for in vitro diagnostic procedures like PGD.
While the device description focuses on the physical characteristics and manufacturing, the intended use clearly places it within the realm of in vitro diagnostic procedures. The pipette is a tool for obtaining a sample that will be analyzed in vitro to provide diagnostic information.
N/A
Intended Use / Indications for Use
Biopsy pipettes are used in assisted reproduction techniques (ART) for the removal of blastomere(s) from embryos or polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic materials in the biopsied cells(s).
Product codes
MQH
Device Description
The Biopsy pipette is part of the RI Pipettes range. Other pipettes available in this range include ICSI Injection, ICSI Holding, and Assisted Hatching pipettes.
Biopsy pipettes are offered in a range
- ID sizes - 14μm, 20μm, 25μm, 30μm, 40μm .
- bend angles 0°, 15°, 20°, 25°, 30°, 35°, 40°, 45° .
- . tip profiles - flat , non-spiked (bevelled), spiked
All pipettes in this range are manufactured from very fine borosilicate glass, packed individually into a Twista-Pak (primary packaging) and sealed in a medical pouch. They are then batch sterilised by gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Each finished batch of pipettes is tested to prove
- . non-pyrogenic by Limulus Amoebocyte Lysate (LAL) per AAMI ST72:2002/(R)2010. Testing acceptance:
§ 884.6130 Assisted reproduction microtools.
(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
RESEARCH INSTRUMENTS LIMITED
Bickland Industrial Park, Faimouth, Cornwall, TR11 4TA, U.K. Tel: 01326 372753 [+44 1326 372 753] Fax: 01326 378783 [+44 1326 378 783] e-mail: sales@research-instruments.com www.research-instruments.com
510(k) Summary
Date prepared
Wednesday, 07 May 2014
Submitter
| Company Name: | Research Instruments Ltd. |
|---|---|
| Registration Number: | 9617095 |
| Address: | Bickland Industrial Park |
| Falmouth, | |
| Cornwall TR11 4TA | |
| United Kingdom | |
| Telephone: | +44 (0) 1326 372 753 |
| Fax: | +44 (0) 1326 378 783 |
| Contact person: | David Lansdowne |
| Contact Title: | Technical Director |
| Contact email: | david@research-instruments.com |
Device Name
Trade Name: RI Pipettes - Biopsy Common name: RI Pipettes Classification Name: Microtools, Assisted Reproduction (21CFR 884.6130, 85 MQH) Classification Panel: Obstetrics/Gynecology 510(K): K133257
Predicate Device
The RI Pipette - Biopsy claim substantial equivalence to two devices which have US market clearance.
Predicate 1
| Trade Name: | RI Pipettes - ICSI Injection, Holding, Assisted Hatching, Denuding |
|---|---|
| Manufacturer: | Research Instruments Ltd |
| Classification Name: | Microtools, Assisted Reproduction |
| 510(K): | K991261 |
| Regulation Number: | 21CFR 844.6130 |
| Product Code: | MQH |
Predicate 2
| Trade Name: | Polar body biopsy micropipet and blastomere biopsy micropipet |
|---|---|
| Manufacturer: | Humagen Fertility Diagnostics, Inc |
| Classification Name: | Microtools, Assisted Reproduction |
| 510(K): | K012811 |
| Regulation Number: | 21CFR 884.6130 |
| Product Code: | MOH |
1
RESEARCH INSTRUMENTS LIMITED
Description of the Device
The Biopsy pipette is part of the RI Pipettes range. Other pipettes available in this range include ICSI Injection, ICSI Holding, and Assisted Hatching pipettes.
Biopsy pipettes are offered in a range
- ID sizes - 14μm, 20μm, 25μm, 30μm, 40μm .
- bend angles 0°, 15°, 20°, 25°, 30°, 35°, 40°, 45° .
- . tip profiles - flat , non-spiked (bevelled), spiked
All pipettes in this range are manufactured from very fine borosilicate glass, packed individually into a Twista-Pak (primary packaging) and sealed in a medical pouch. They are then batch sterilised by gamma irradiation.
Summary of Performance Testing
Each finished batch of pipettes is tested to prove
- . non-pyrogenic by Limulus Amoebocyte Lysate (LAL) per AAMI ST72:2002/(R)2010. Testing acceptance: Trade/Device Name: RI Pipettes - Biopsy Regulation Number: 21 CFR§ 884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: II Product Code: MQH Dated: April 14, 2014 Received: April 14, 2014
Dear David Lansdowne,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
3
Page 2 - David Lansdowne
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDeyices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133257
Device Name
RI Pipettes - Biopsy
Indications for Use (Describe)
Biopsy pipettes are used in assisted reproduction techniques (ART) for the removal of blastomere(s) from embryos or polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic materials in the biopsied cell(s).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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